The application of uncertainty to USP's compendial reference standards program: Certified reference materials

Pharmacopeial Forum

Volumn 33, Issue 6, 2007, Pages 1300-1305

  Manning, Ronald G ^a   Lane, Steven ^a   Dressman, Shawn ^a   Hauck, Walter W ^a   Williams, Roger L ^a   Palermo, Philip J ^c   Borer, Matthew W ^b   Fay, David ^c   Gomas, Anthony Raj ^d   Jin, Shaohong ^e   Lee, Judy ^f   Santoro, Maria Ines ^g  

^a UNITED STATES PHARMACOPEIA   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c Tyco Healthcare/Mallinckrodt ^*

^d DR REDDY'S LABORATORIES LTD   (India)

^e NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS   (China)

^f PURDUE PHARMA L P   (United States)

^g UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; DRUG; EXCIPIENT; FOOD ADDITIVE;

ARTICLE; DIET SUPPLEMENTATION; DOCUMENTATION; DRUG FORMULARY; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; GOVERNMENT; MEDICAL LITERATURE; STANDARD; UNCERTAINTY; UNITED STATES;

EID: 44649200281     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Williams RL, Project Team 4, the 2000-2005 Reference Standards Committee of the USP Council of Experts and Its Advisory Panel, USP Staff, Consultant. Official USP reference standards: metrology concepts, overview, and scientific issues and opportunities. J Pharm Biomed Anal. 2006;40:3-15.
2. FDA. Pharmaceutical CGMPs for the 21* century - a risk-based approach. September 2004. www.fda.gov/ohrms/dockets/ac/04/ briefing/ 2004-4078BI-08-CGMP-Report.pdf. Accessed 07 June 2005.
3. ISO. Guide 17025 - General Requirements for the Competence of Testing and Calibration Laboratories. Geneva, Switzerland: ISO; 2005.
4. FDA. Disposition of FY 2006 performance goals. 09 February 2006. www.fda.gov/oc/oms/ofin/budget/2007/HTML/3Disposition Table.htm. Accessed 07 June 2007.
5. ISO. Guide 43 - Proficiency Testing by Interlaboratopy Comparisons. Part 1: Development and Operation of Proficiency Testing Schemes and Part 2: Selection and Use of Proficiency Testing Schemes by Laboratory Accreditation Bodies. Geneva, Switzerland: ISO; 1997.
6. ISO. Guide 30 - Terms and Definitions Used in Connection with Reference Materials (1992)
7. ISO Guide 31 - Reference Materials - Contents of Certificates and Labels (2000)
8. ISO Guide 32 - Calibration in Analytical Chemistry and Use of Certified Reference Materials (1997)
9. ISO Guide 33 - Uses of Certified Reference Materials (2000)
10. ISO Guide 34 - General Requirements for the Competence of Reference Material Producers (2003)
11. ISO Guide 35 - Reference Materials - General and Statistical Principlesfor Certification (2006). Geneva, Switzerland: ISO; [dates as shown].
12. ISO. Guide 98 - Guide to the Expression of Uncertainty in Measurement (GUM). Geneva, Switzerland: ISO; 1995.
13. ASME. Guidelines for decision rules: considering measurement uncertainty in determining conformance to specifications. ASME B89.7.3.1-2001. ASME; 2001:4.